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ICU Medical, Inc.

ICU MEDICAL, INC. · Model B2229 · UDI-DI 00887709128071

FMG Prescription

510(k) clearances

6,009

Adverse events (25 deaths)

207

Recalls

Facilities

Description

GTIN for B2229, 92" (234 cm) Appx 10.4 ml 15 Drop Admin Set w/5.0 Micron Filter, Inj Site, Spin Luer, 1/EA

Recalls

Date	Firm	Reason
2026-05-21	BD SWITZERLAND SARL	Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has
2026-05-12	ICU Medical, Inc.	Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with
2026-05-12	ICU Medical, Inc.	Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with
2025-10-29	B Braun Medical Inc	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29	B Braun Medical Inc	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29	B Braun Medical Inc	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29	B Braun Medical Inc	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29	B Braun Medical Inc	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29	B Braun Medical Inc	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29	B Braun Medical Inc	Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.